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Background There is a critical need for carbapenem-sparing therapies for infections caused by extended spectrum β-lactamase (ESBL)-producing Enterobacterales. Enmetazobactam is a novel ESBL inhibitor combined with the cephalosporin cefepime. Treatment outcomes of cefepime-enmetazobactam (FPE) versus piperacillin-tazobactam (PTZ) were assessed in subgroups of patients with ESBL-producing baseline uropathogens (ESBL-BU) in the ALLIUM phase 3 trial of complicated urinary tract infections (cUTI)/acute pyelonephritis (AP). Methods 1034 cUTI/AP patients randomized 1:1 in a double-blind, multicenter trial received either 2 g cefepime/0.5 g enmetazobactam or 4 g piperacillin/0.5 g tazobactam q8h by 2h infusion for 7 to 14 days. Enterobacterales with MICs ≥1 µg/ml to ceftazidime, ceftriaxone, cefepime, meropenem, or FPE were genotyped for β-lactamases. In addition to the primary analysis (by stratified Newcombe) of overall success (combination of clinical cure and microbiological eradication) in the microbiological modified intent to treat population (mMITT) at test-of-cure (TOC), subgroup analyses were performed on patients with ESBL-BU non-resistant to FPE (MIC≤8 µg/ml) and PTZ (MIC≤64 µg/ml) and a subgroup (mMITT+R) that also included the ESBL-BU resistant to either agent (FPE MIC ≥16 µg/ml or PTZ MIC≥128 µg/ml). Results In mMITT, FPE (273/345, 79.1%) demonstrated superiority to PTZ (196/333, 58.9%) at TOC (difference, 21.2%; 95% CI: 14.3, 27.9). The prevalence rate of ESBL-BU was 20.9% (142/678), with 99.3% (141/142) expressing a CTX-M-type (-1, -3, -9, -14, -15, -27, -55, -91, -169) and 3.5% (5/142) co-expressing AmpC (CMY-2/-59). FPE (56/76, 73.7%) demonstrated superiority to PTZ (34/66, 51.5%) in this subgroup at TOC (difference 30.2%; 95% CI: 13.4, 45.1; Table). In mMITT+R, the ESBL-BU prevalence rate was 22.3% (172/771), with 6.4% (11/172) co-expressing AmpC (CMY-2/-4/-59/-99), 4.7% (8/172) co-expressing a metallo-β-lactamase (VIM-1, NDM-1), and 2.3% (4/172) co-expressing OXA-48. Superiority of FPE (67/91, 73.6%) compared to PTZ (41/81, 50.6%) was also observed at TOC despite inclusion of ESBL-BU resistant to either agent (difference 30.0%; 95% CI: 14.9, 43.3). Table Conclusion FPE may represent a new empiric carbapenem-sparing option in settings where ESBL are endemic. Disclosures Adam Belley, PHD, Allecra Therapeutics SAS (Consultant) Philip Barth, MD, Allecra Therapeutics SAS (Consultant) Shikhar Kashyap, n/a, Allecra Therapeutics SAS (Consultant)Allecra Therapeutics SAS (Consultant) Omar Lahlou, PhD, Allecra Therapeutics SAS (Employee) Paola Motta, PhD, Allecra Therapeutics SAS (Employee) Patrick Velicitat, MD, Allecra Therapeutics SAS (Employee)

open forum infectious diseases

LB-4. Cefepime-Enmetazobactam Demonstrates Superiority to Piperacillin-Tazobactam in a Subgroup of Patients with Complicated Urinary Tract Infections/Acute Pyelonephritis Caused by Extended Spectrum β-Lactamase-Producing <i>Enterobacterales</i>

LB-4. Cefepime-Enmetazobactam Demonstrates Superiority to Piperacillin-Tazobactam in a Subgroup of Patients with Complicated Urinary Tract Infections/Acute Pyelonephritis Caused by Extended Spectrum β-Lactamase-Producing Enterobacterales